FDA Inspection
Eisertech LLCEisertech LLC – FDA Inspection, Sep 2, 2015
Record Details
This FDA Inspection record concerns Eisertech LLC, with an inspection on September 2, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Eisertech LLC
- Inspection Date
- September 2, 2015
- Product Type
- Devices
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ID · bceedf41-5b7d-4e67-9ed6-504603f0b52f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941366
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of Eisertech LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 19, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Eisertech LLC
- FDA Inspection 1100060 - 2019-08-21
- FDA Inspection 813940 - 2012-12-19
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